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Effects of Anamorelin on Cancer-Related-Fatigue in Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT03035409
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Helsinn Healthcare SA
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if anamorelin can help to decrease cancer-related fatigue in patients with advanced cancer.

The safety of this drug in combination with physical activity will also be studied.

This is an investigational study. Anamorelin is not FDA approved or commercially available. Its use in combination with physical activity is investigational. The study doctor can explain how the study drug is designed to work.

Up to 38 participants will be enrolled in this study. All will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
Malignant Neoplasms of Independent (Primary) Multiple Sites Advanced Cancer Metastatic or Recurrent Incurable Solid Tumors Drug: Anamorelin Behavioral: Physical Activity Behavioral: Assessment Questionnaires Behavioral: Counseling Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Anamorelin on Cancer-Related-Fatigue in Patients With Advanced Cancer
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Anamorelin

Participants take Anamorelin by mouth 1 time each day for 6 weeks.

Participants perform resistance exercises and a walking program at home for 6 weeks while also taking Anamorelin.

Assessment questionnaires completed at baseline, on Days 8, 15, 21, 29, 36, and 43.

Participants meet with a dietitian for nutrition counseling on Day 21, and an exercise specialist on Day 15.

Drug: Anamorelin
100 mg by mouth 1 time each day for 6 weeks.

Behavioral: Physical Activity
Participants perform resistance exercises and a walking program at home for 6 weeks while also taking Anamorelin.

Behavioral: Assessment Questionnaires
Assessment questionnaires completed at baseline, on Days 8, 15, 21, 29, 36, and 43.
Other Name: Surveys

Behavioral: Counseling
Participants meet with a dietitian for nutrition counseling on Day 21, and an exercise specialist on Day 15.




Primary Outcome Measures :
  1. Difference Between the Functional Assessment of Cancer Illness Therapy-Fatigue (FACIT-F) Subscale Score at Baseline and Day 43 [ Time Frame: 43 Days ]

Secondary Outcome Measures :
  1. Effects of Anamorelin and Standardized Physical Activity as Measured by The Multidimensional Fatigue Symptom Inventory-Short Form[MFSI-SF] [ Time Frame: 43 Days ]
  2. Effects of Anamorelin and Standardized Physical Activity as Measured by PROMIS Fatigue Measure [ Time Frame: 43 Days ]
  3. Effects of Anamorelin and Standardized Physical Activity as Measured by Hospital Anxiety Depression Scale (HADS) [ Time Frame: 43 Days ]
  4. Effects of Anamorelin and Standardized Physical Activity as Measured by Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: 43 Days ]
  5. Effects of Anamorelin and Standardized Physical Activity as Measured by Functional Assessment of Cancer Therapy (FACT-G) [ Time Frame: 43 Days ]
  6. Effects of Anamorelin and Standardized Physical Activity as Measured by Functional Assessment of Anorexia/Cachexia Treatment (FAACT) [ Time Frame: 43 Days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors excluding prostate cancer)
  2. Presence of fatigue on FACIT-F subscale of </= 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 =worst possible fatigue)
  3. Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
  4. CRP must be >/= 3mg/l* in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder.
  5. No evidence of moderate to severe depression as determined by a HADS depression score of </=13
  6. Presence of unintentional weight loss ranging from >/= 2 - </=15% at any time within the last 12 months
  7. Uncontrolled pain; If patient is on opioids for the treatment of cancer pain, he/she must have had no major dose change (>25%) for at least 48 hours prior to study entry. The dose of morphine equivalent daily should not exceed 120mg/day unless approved by the PI. Change in opioid dose after study entry is allowed;
  8. Patient must be 18 years of age or older. The questionnaires used in this study have been validated only in the adult population
  9. Patient must be willing to engage in telephone follow up with research staff
  10. Patient must have telephone access to be contacted by the research staff
  11. Hemoglobin level of >/=9 g/dL
  12. Estimated life expectancy of > 4 months at the time of screening
  13. Adequate hepatic function, defined as aspartate transaminase (AST) and alanine transaminase (ALT) levels </= 5 × upper limit of normal (ULN)

Exclusion Criteria:

  1. Major contraindications to anamorelin e.g. hypersensitivity
  2. Regularly engaged in moderate or vigorous-intensity exercise for at least 5 times a week
  3. Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
  4. Pregnant or lactating women, childbearing age women who are not on birth control. Negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months. Pregnancy test to be performed no greater than 14 days prior to consent in study. In cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy. Women of childbearing potential need to be on or use contraception, or be abstinent during the study period. Their male partners must also use contraception (condom) or maintain abstinence. Birth controls specifications: Women who are able to become pregnant must use birth control during the study and for 30 days after the last Anamorelin dose. Acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide.
  5. Uncontrolled diabetes mellitus ( Fasting Blood Sugar >200mg/dl) at screening
  6. Male patients with a history of untreated hypogonadism
  7. Patients on drugs with strong CYP 3A4 inhibitors within the previous two weeks (ketoconazole, clarithromycin, itraconazole, nefazodone, telithromycin)
  8. Patients on drugs that may prolong the PR or QRS interval durations, such as any of the Class I/Sodium (Na+) Channel blocking antiarrhythmic medications should be avoided (e.g. Flecainide, Procainamide, Propafenone, Quinidine).
  9. Patients with untreated clinically relevant hypothyroidism
  10. Patients currently on investigational therapies will be evaluated by the PI on a case by case basis and study participation approval will be obtained from the treating oncologist.
  11. Patients with prostate cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035409


Contacts
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Contact: Sriram Yennu, MD 713-792-6085 syennu@mdanderson.org

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       syennu@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Helsinn Healthcare SA
Investigators
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Principal Investigator: Sriram Yennu, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03035409     History of Changes
Other Study ID Numbers: 2016-0655
NCI-2017-00188 ( Registry Identifier: NCI CTRP )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of independent (primary) multiple sites
Advanced Cancer
Metastatic or recurrent incurable solid tumors
Anamorelin
Physical activity
Questionnaires
Surveys
Dietary Counseling
Exercise Counseling

Additional relevant MeSH terms:
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Fatigue
Neoplasms
Signs and Symptoms